Need to be
MHRA Inspection-Ready?
We'll Get You There.
For pharmaceutical startups who need GMP certification — without the panic. Fixed scope. Named consultant. No billable-hour surprises.
Not all consultancies fit everyone.
We work best with a specific type of client. If this sounds like you, let's talk.
The Compliance Newcomer
Technically sharp — scientist or pharmacist by training — but you've hit a wall on regulatory compliance. An MHRA inspection is on the calendar and you need someone who's done this before. Yesterday.
- "How do we achieve GMP certification from scratch?"
- "Does our product need FDA approval? We don't know where to start."
- "We have an MHRA inspection in 8 weeks and are not prepared."
The Overstretched QA Manager
You know your stuff but the volume is overwhelming. A new market entry, an FDA submission, a system upgrade — you need a specialist who can slot in and deliver without hand-holding.
- "We need regulatory backup for a specific project — not a full retainer."
- "How do we structure this IMPD for MHRA submission?"
- "Our QMS documentation needs to hold up to a third-party audit."
The Operator at an Inflection Point
You're running a business that needs an external perspective — market expansion, operational efficiency, or regulatory strategy for a new product line. Formal consulting engagement. Decision cycle 1–4 months.
- "We need a structured approach to scaling up our manufacturing."
- "Market expansion — what does the regulatory pathway look like?"
- "External perspective on our unit economics and business model."
Two services. One principle:
We only make money when you make money. Every engagement is structured around your outcomes, not our billable hours.
Pharmaceutical Manufacturing Consulting
Got an MHRA inspection on the horizon? We'll make sure your documentation, process validation, and CAPA records hold up to scrutiny — and that your team knows why.
- Process validation strategy and documentation review
- Tech transfer packages — incoming and outgoing
- Deviation investigation and CAPA root cause analysis
- Supplier and materials qualification programmes
- MHRA/FDA pre-inspection readiness reviews
- Regulatory submission support (IMPD, CTA, NDA)
- Named senior consultant — contractually committed to your project
Operational & Business Strategy
Companies at an inflection point. Growth stalled, unit economics unclear, or pivoting your business model? We bring the same structured thinking that works in regulated pharma to your commercial strategy.
- Business Model Canvas (Osterwalder framework)
- Strategic Growth Diagnostic — top 3 revenue/profit bottlenecks
- Unit economics analysis and 3-year financial projection
- Operational process design and documentation
- Regulatory compliance frameworks for adjacent sectors
- Ad hoc strategic sessions (pre-paid, no expiry)
- 60-day post-delivery accountability review
The same skills — other sectors
Every engagement starts with a conversation. We find out if we're the right fit — and we'll tell you if we're not.
Pharmaceutical Manufacturers
MHRA/FDA-approved sites needing process validation, tech transfer, or regulatory submission support.
Food Supplement Brands
Translating GMP-compliant manufacturing standards into a quality story for retail and online channels.
Medical Device Companies
Quality management system documentation, supplier audits, and regulatory submission preparation.
Contract Manufacturers
Tech transfer management, capacity planning, and client qualification programme delivery.
Any Business at an Inflection Point
Structured strategy, clear financial framing, and a named consultant who owns your outcomes.
Investors & Acquirers
Operational due diligence on manufacturing assets, regulatory exposure assessment, and gap analysis.
How it works
Transparent milestones from day one. No black-box engagements.
Email First
Send us a brief note about your situation. We'll respond within one business day to arrange a call if there's a potential fit.
Strategy Call
30-minute call to understand your business, your regulatory environment, and your barriers. No hard sell — if we're not a fit, we'll tell you.
Proposal & Contract
A clear proposal with defined deliverables, fixed pricing, and measurable outcomes. Signed and agreed before any work begins.
Execution & Review
Named consultant drives delivery. Fortnightly check-ins. Monthly written briefings. 60-day review at project close.
Ready to talk
to someone who understands?
Email us with a brief description of your situation. We'll respond within one business day.
No commitment required. If we're not the right fit, we'll tell you — and point you in the right direction.
info@pbaventures.co.ukPrefer a form? Send us an enquiry.